Vented vacuum bandage and method

ABSTRACT

A ventilated bandage system is provided for use with a wound. The system includes a bandage positioned adjacent the wound to create a sealed environment around the wound. A vacuum source of the system is in communication with the bandage to create negative pressure between the bandage and the wound. The system may also include a first passageway or vent in communication with the bandage and with the surrounding atmosphere, and a second passageway in communication with the bandage and with the vacuum source.

BACKGROUND OF THE INVENTION

The present disclosure relates to vacuum therapy wound treatment systemsincluding a vacuum bandage coupled to a vacuum source and an irrigationsource.

The prior art contemplates that chronic wounds may be treated byproviding a vacuum in the space above the wound to promote healing. Anumber of prior art references teach the value of the vacuum bandage orthe provision of vacuum in the space above the surface of a chronicwound.

A vacuum bandage is a bandage having a cover for sealing about the outerperimeter of the wound and under which a vacuum is established to act onthe wound surface. Applying vacuum to the wound surface promotes healingof chronic wounds. Typically, suction tubes are provided for drawingexudate away from the wound and for creating a vacuum under the cover.The following U.S. patents establish the nature of vacuum treatmentbandages and devices: U.S. Pat. Nos. 6,095,992; 6,080,189; 6,071,304;5,645,081; 5,636,643; 5,358,494; 5,298,015; 4,969,880, 4,655,754;4,569,674; 4,382,441; and 4,112,947. All of such references areincorporated herein by reference.

Further, the prior art contemplates that wounds may be treated byproviding irrigation in the space above the wound. Typically, a tube isprovided in communication with the wound surface of the wound at one endand with an irrigation source an another end. The fluid from theirrigation source travels through the tube to the wound surface.

The prior art further contemplates the use of stopcocks for use inintravenous injections and infusions. Stopcocks may be designed toinclude multiple ports for directing fluid flow along various paths orchannels. The following U.S. patents establish the nature of stopcocks:U.S. Pat. Nos. 6,158,467; 3,586,049; 2,485,842; 2,842,124; and U.S.Patent Application Publication No. US 2001/00 13370 A1.

SUMMARY OF THE INVENTION

The present invention comprises one or more of the following features orcombinations thereof:

A wound care bandage system is provided for use with a wound. Thesystem, among other things, may be capable of ventilating the wound. Thesystem may include a vacuum source, an irrigation source, a vent incommunication with the surrounding atmosphere and with the wound, and abandage. The vacuum source creates negative pressure above the wound andthe irrigation source irrigates the wound. As is herein defined, theterm “vent” is or includes any passageway to the atmosphere, unlessnoted otherwise.

The bandage is configured to lie adjacent the wound to create a sealedenvironment about the wound. The vent may be positioned between thebandage and the vacuum source. A vacuum passageway of the system mayextend between the bandage and the vacuum source, and a vent passagewayof the system may extend from the bandage to the vent in communicationwith the surrounding atmosphere. The vacuum passageway may extendthrough the vent to the vacuum source.

The system may also include a multi-lumen tube which forms the vacuumpassageway and the vent passageway, and a wound dressing member coupledto the multi-lumen tube configured to lie adjacent the wound. Themulti-lumen tube may be configured to couple to the vacuum bandage andmay include a venting lumen in communication with the surroundingatmosphere and another vacuum/irrigation lumen in communication witheither or both of the vacuum source and the irrigation source. Further,the multi-lumen tube may include a vacuum lumen and a separateirrigation lumen distinct from the vacuum lumen.

The system may also include a vent-valve apparatus having the vent or aportion of the vent passageway formed therein. The apparatus providesselective communication between the wound and either the vacuum sourceor the irrigation source. The apparatus may include a multi-lumenconnector configured to communicate with the bandage. The multi-lumenconnector may include at least one inner conduit in communication withthe vacuum source and/or the irrigation source and at least one outerconduit in communication with the atmosphere. The apparatus may furtherinclude a vacuum connector coupled to the vacuum source and anirrigation connector coupled to the irrigation source. An opening of theapparatus may be provided to communicate with the atmosphere and withthe outer conduit of the multi-lumen connector.

In one embodiment, the apparatus may include a vent having themulti-lumen connector, and a stopcock coupled to the vent and includingthe vacuum connector and the irrigation connector. The vent may includea single-lumen connector coupled to the inner conduit of the multi-lumenconnector. The vent may further include a housing and a filter housedwithin the housing. The filter may be in communication with thesurrounding atmosphere and with the outer conduit of the multi-lumenconnector through the opening.

The stopcock may include a single-lumen connector coupled to thesingle-lumen connector of the vent and a diverter to selectively couplethe single-lumen connector of the stopcock with either the vacuumconnector or with the irrigation connector. The stopcock may furtherinclude a body and the diverter may be coupled to the body forrotational movement relative to the body. The diverter may include acut-out portion to selectively communicate the vacuum connector or theirrigation connector with the vent.

In another embodiment, the apparatus may include a body or outer shelldefining an aperture and a diverter or inner barrel received within theaperture. The diverter may rotate relative to the outer shell toselectively communicate with the vacuum source or the irrigation source.The outer shell may include the multi-lumen connector, the vacuumconnector, and the irrigation connector. The diverter may include afirst set of passageways and a second set of passageways formedtherethrough. The first set of passageways communicates with the innerconduit of the multi-lumen connector, the vacuum connector, and theirrigation connector. The second set of passageways may communicate withthe outer conduit of the multi-lumen connector through a groove orchannel formed in the outer shell between the outer conduit and thesecond set of passageways. The outer shell illustratively includes theopening of the apparatus and the second set of passageways is inselective communication with the opening. A filter may be coupled to theopening.

In yet another embodiment, the apparatus may include a vent and astopcock coupled to the vent. The vent may include a multi-lumenconnector and a first and second single-lumen connector. The stopcockmay include a vacuum connector and an irrigation connector. The vacuumconnector may include a first portion coupled to the first single-lumenconnector of the vent and a second portion coupled to the vacuum source.The irrigation connector may include a first portion coupled to thesecond single-lumen connector of the vent and a second portion coupledto the irrigation source.

The inner conduit of the multi-lumen connector may be a vacuum conduitand the multi-lumen connector may further include an irrigation conduit.Each of the vacuum and irrigation conduits may be positioned within theouter conduit. The vacuum conduit may be coupled to the firstsingle-lumen connector of the vent and the irrigation conduit may becoupled to the second single-lumen connector of the vent. The ventfurther may include a housing coupled to the multi-lumen connector and afilter within the housing. The filter may be in communication with thesurrounding atmosphere and with the opening through a passageway of thehousing.

The stopcock may include a body coupled to the vacuum and irrigationconnectors and a diverter received within an aperture of the body. Eachof the first, and second portions of the vacuum and irrigationconnectors may communicate with the aperture of the body. The vacuumconnector may illustratively lie in a first horizontal plane and theirrigation connector may illustratively lie in a second horizontalplane.

The diverter may include a first cut-out portion for communication withthe vacuum connector and a second cut-out portion for communication withthe irrigation connector. The diverter may rotate relative to the bodyto connect the first and second portions of the vacuum connector witheach other and to connect the first and second portions of theirrigation connector with each other to selectively communicate thevacuum source and the irrigation source to the wound.

Other features of the invention will become apparent to those skilled inthe art upon consideration of the following detailed description of thepreferred embodiments exemplifying the best mode of carrying out theinvention as presently perceived.

BRIEF DESCRIPTION OF THE DRAWINGS

The detailed description particularly refers to the accompanying figuresin which:

FIGS. 1-8 illustrate components of a wound care bandage system of thepresent disclosure which provides suction, irrigation, and ventilationto a wound;

FIG. 1 is a part perspective, part diagrammatic view of the wound carebandage system located on the leg of a patient and coupled to a vent andto vacuum and irrigation sources through the use of a stopcock or aswitch valve;

FIG. 2 is a perspective view of the vent of the system showing amulti-lumen connector for communication with the wound via a multi-lumentube, a single-lumen connector for communication with the switch valve,and a circular housing holding a filter (in phantom) in communicationwith the surrounding atmosphere;

FIG. 3 is a side view of the vent, with portions broken away, showingthe multi-lumen connector aligned for coupling to the multi-lumen tube,the single-lumen connector aligned for coupling to a single lumen tube,a passageway of the vent extending between outer lumens of themulti-lumen tube and the filter of the vent, and further showing a thin,flexible wound dressing member of the bandage coupled to the multi-lumentube by a barbed coupler;

FIG. 4 is a sectional view of the multi-lumen tube taken along line 4-4of FIG. 3 showing an inner lumen of the tube for communication with thevacuum source and the irrigation source of the system and four outerlumens of the tube for communication with the filter and surroundingatmosphere to aspirate an area above the wound;

FIG. 5 is an exploded perspective view of the switch valve and vent ofthe system showing a vent connector of the valve aligned for coupling tothe single-lumen connector of the vent, a vacuum connector forcommunication with the vacuum source, an irrigation connector forcommunication with the irrigation source, and a handle or diverter forproviding selective communication between the vent connector and eitherthe vacuum source or the irrigation source;

FIGS. 6 a and 6 b are perspective views of the handle of the switchvalve showing a grip and a stem of the handle and further showing acut-out portion of the stem for selective communication between thevent, vacuum, and irrigation connectors of the switch valve;

FIG. 7 is a sectional view taken along line 7-7 of FIG. 5 showing thehandle of the switch valve in an irrigation position so that the cut-outportion provides a passageway between the irrigation connector and thevent connector to permit fluid from the irrigation source to run throughthe switch valve to the wound;

FIG. 8 is a sectional view similar to FIG. 7 showing the handle of theswitch valve in a vacuum position so that the cut-out portion provides apassageway between the vacuum connector and the vent connector to permitthe vacuum source to draw fluid and exudate from the wound;

FIGS. 9-16 illustrate components of another wound care bandage system inaccordance with the present disclosure which also provides suction,irrigation, and ventilation to the wound;

FIG. 9 is a part perspective, part diagrammatic view similar to FIG. 1showing the wound care bandage system of FIGS. 9-16 including atwo-level stopcock or switch valve in selective communication with thebandage, vacuum source, and irrigation source of the system, and furthershowing the two-level stopcock including a vent coupled to a filter;

FIG. 10 is an exploded view of the two-level stopcock showing an innerbarrel or handle and an outer shell, with portions broken away, andfurther showing the inner barrel having a grip and a stem including anupper level of ports for communication with either the vacuum source orthe irrigation source, depending on the position of the inner barrelrelative to the outer shell, and a lower level of ports forcommunication with the vent, and further showing an inner vent groove ofthe outer shell for providing communication between the outer lumens ofthe multi-lumen tube and the lower level ports of the barrel;

FIGS. 11-16 show three positions of the two-level stopcock provided bymoving the inner barrel relative to the outer shell to selectively aligncertain upper level ports of the inner barrel with the vacuum andirrigation connectors of the outer shell and to selectively aligncertain lower level ports with the vent of the outer shell;

FIGS. 11 and 12 show the two-level stopcock in a vented vacuum positionso that the vacuum source and vent are in communication with the woundto create a negative pressure adjacent the wound while drawing air intothe system through the vent and over the wound to aspirate thepassageways of the system;

FIG. 11 is a top view of the two-level stopcock in the vented vacuumposition showing a passageway (in phantom) connecting the vacuumconnector and the multi-lumen tube connector;

FIG. 12 is a sectional view taken along line 13-13 of FIG. 9 when thetwo-level stopcock is in the vented vacuum position showing ventingpassageways of the inner barrel and showing one passageway connectingthe vent groove of the outer shell with the vent;

FIGS. 13 and 14 show the two-level stopcock in a vacuum position whereonly the vacuum source is in communication with the wound to create anegative pressure adjacent the wound;

FIG. 13 is a top view similar to FIG. 11 of the stopcock in the vacuumposition after the handle has been turned clockwise from the ventedvacuum position shown in FIG. 11, and showing a passageway (in phantom)between the vacuum connector and the multi-lumen tube connector;

FIG. 14 is a sectional view similar to FIG. 12 showing the two-levelstopcock in the vacuum position where none of the venting passageways ofthe inner barrel connect the vent groove of the outer shell with thevent;

FIGS. 15 and 16 show the two-level stopcock in a vented irrigationposition where the irrigation source and the vent are in communicationwith the wound;

FIG. 15 is a top view similar to FIGS. 11 and 13 showing the two-levelstopcock in the vented irrigation position after the handle has beenturned clockwise from the vacuum position shown in FIG. 13, and showinga passageway (in phantom) between the irrigation connector and themulti-lumen connector;

FIG. 16 is a sectional view similar to FIGS. 12 and 14 showing thetwo-level stopcock in the vented irrigation position and showing apassageway of the inner barrel connecting the vent groove of the outershell with the vent;

FIGS. 17-19 show a multi-lumen tube coupler according to the presentdisclosure for use with either of the systems illustrated in FIGS. 1-8and FIGS. 9-16 described above for coupling two multi-lumen tubestogether;

FIG. 17 is a part perspective, part diagrammatic view of the multi-lumentube coupler in use with the system shown in FIGS. 9-16;

FIG. 18 is a perspective view of the multi-lumen tube coupler showing aninner passageway for communication with each inner lumen of themulti-lumen tubes and an outer passageway for communication with eachouter lumen of the multi-lumen tubes, and also showing a contoured uppersurface and a flat bottom surface of the tube coupler;

FIG. 19 is a sectional view of the multi-lumen tube coupler coupled totwo multi-lumen tubes showing a flow path of fluids through themulti-lumen tubes and the coupler;

FIGS. 20-28 illustrate components of yet another wound care bandagesystem in accordance with the present disclosure for providing suction,irrigation, and ventilation to the wound;

FIG. 20 is a part perspective, part diagrammatic view similar to FIG. 1showing the wound care bandage system of FIGS. 20-28 including a ventcoupled to the bandage via a multi-lumen tube (shown in FIG. 21) and astopcock or switch valve coupled to the vent (via two single-lumentubes) to provide selective communication between the bandage and theirrigation and vacuum sources;

FIG. 21 is an end view of the multi-lumen tube of the system shown inFIGS. 20-28 showing the tube including a vacuum lumen, an irrigationlumen, and four outer vent lumens formed within a body of the tube;

FIG. 22 is a perspective view of a “Y-connecter” of the system shown inFIGS. 20-28 for coupling the wound dressing member of the bandage withthe multi-lumen tube shown in FIG. 21 showing a bandage portion of theconnector for insertion within a connector of the member, a vacuumportion for insertion within the vacuum lumen of the multi-lumen tube,and an irrigation portion for insertion within the irrigation lumen ofthe multi-lumen tube;

FIG. 23 is a perspective view of the vent of the system shown in FIG. 20showing a multi-lumen connector for coupling with the multi-lumen tubeof FIG. 21, a vacuum connector for communication with the vacuum sourcevia a single-lumen tube, an irrigation connector for communication withthe irrigation source via a separate single-lumen tube, and also showinga filter housing coupled to the multi-lumen connector for communicationwith the venting lumens of the multi-lumen tube and with the atmosphere;

FIG. 24 is a sectional view of the vent coupled to the multi-lumen tubeand the two single-lumen tubes showing a filter of the vent (inphantom), the separate vacuum, irrigation, and vent passageways formedthrough the vent, and also showing the Y-connecter of the system coupledto the multi-lumen tube and to the member;

FIG. 25 is an exploded perspective view of the stopcock or switch valveof the system shown in FIGS. 20-28 showing two separate passagewaysthrough a body of the stopcock for separate communication with thevacuum source and the irrigation source, and showing a handle ordiverter, having two cut-out portions, to be received within the body ofthe stopcock;

FIGS. 26-28 are sectional views showing the stopcock in an irrigationposition, a vacuum position, and an off position;

FIG. 26 is a sectional view of the stopcock showing the stopcock in thevacuum position so that a first cut-out portion of the handle creates apassageway between first and second portions of a vacuum conduit of thestopcock;

FIG. 27 is a sectional view similar to FIG. 26 showing the stopcock inthe irrigation position where the handle has been rotated in a clockwisedirection from that shown in FIG. 26 so that a second cut-out portion(shown in phantom) connects first and second portions of an irrigationconduit with each other;

FIG. 28 is a sectional view similar to FIGS. 26 and 27 showing thestopcock in the off position where the handle has been rotated 180degrees from that shown in FIG. 27 so that neither the first nor thesecond cut-out portions connect the first and second portions of eitherof the vacuum conduit or the irrigation conduit;

FIGS. 29-31 illustrate components of still another vacuum bandage systemof the present disclosure which provides suction, irrigation, andventilation to a wound;

FIG. 29 is a part perspective and part diagrammatic view of a vacuumbandage system of the present disclosure showing a wound dressing memberof the bandage including a cover having a port and a wound contactinglayer having a wound contacting surface and channels formed in anopposite surface to cooperate with the cover and form passageways of themember in communication with the port and a vacuum source and/or anirrigation source, and also showing a vent line or tube having a firstend for communication with the passageways and a second end incommunication with the surrounding atmosphere through a filter and acap;

FIG. 30 is a sectional view of the bandage of FIG. 29 positioned withina wound and showing a sealing film of the bandage providing a sealedvacuum space above the wound, the first end of the vent line incommunication with the vacuum space, and the second end of the vent linecoupled to the filter and to the cap outside of the vacuum space;

FIG. 31 is a sectional view taken along line 31-31 of FIG. 30 showingthe vent line and a vacuum tube coupled to each other by a coupler;

FIG. 32 is a sectional view of an alternative vent line and vacuum tubeshowing a multi-lumen tube having a vent passageway and a vacuum tubepassageway formed therein and separated by a partition; and

FIG. 33 is a sectional view of yet another vent line and vacuum tubecombination showing an outer wall of the vent line and an outer wall ofthe vacuum tube integrally coupled to one another to form a singlemulti-lumen tube.

DETAILED DESCRIPTION OF THE DRAWINGS

A wound care bandage system is provided which has the capability tocreate negative pressure adjacent the wound, to irrigate the wound, andto ventilate the wound. A vent of the system is provided to communicatewith the wound and with the surrounding atmosphere. In some embodiments,a vent-valve apparatus or a vent and valve combination of the system isin communication with the wound and with a vacuum source and anirrigation source of the wound. The vent-valve apparatus includes thevent which is in communication with the surrounding atmosphere and adiverter to provide selective communication between the wound and theirrigation source or between the wound and the vacuum source, as isdescribed in greater detail below.

One embodiment of a wound care bandage system 10 is shown in FIGS. 1-8and is provided to allow a caregiver to create a negative-pressure abovea wound surface (not shown) of a wound 200 (see FIG. 20) through the useof an illustrative vacuum bandage 14 and a vacuum source 16, as shown inFIG. 1. System 10 further allows a caregiver to irrigate the woundsurface through the use of an irrigation source 18. Additionally, system10 ventilates the wound during the application of negative pressure tothe wound and irrigation of the wound through use of a vent 19 incommunication with the surrounding atmosphere.

The system 10 further includes a stopcock or switch valve 50 coupled tovent 19. Switch valve 50 allows a caregiver to selectively providecommunication between the wound and either vacuum source 16 orirrigation source 18. As is herein defined, the terms switch valve andstopcock are used interchangeably to describe an apparatus forselectively controlling and/or diverting fluid flow therethrough. Asshown in FIG. 1, switch valve 50 is coupled to vent 19 via asingle-lumen tube 52. However, switch valve 50 may also be coupleddirectly to vent 19, as shown in FIG. 5 and described in more detailbelow. The vent 19 and switch valve 50 (and tube 52, if used) cooperateto create a vent-valve assembly 80 to allow a caregiver to togglebetween different modes such as vented vacuum therapy and ventedirrigation therapy. The system 10 incorporates two separate fluid lines.One fluid line selectively provides vacuum suction or irrigation to thewound while the other fluid line vents the system 10 by providingcommunication between the wound and the surrounding atmosphere to createair flow above the wound.

Vacuum bandage 14, as shown in FIG. 1, is provided for use with thewound and is sealed about the wound by a cover or sealing film 13 ofbandage 14 to create a sealed environment between the wound and sealingfilm 13 in which a negative pressure can be established. Bandage 14 isselectively coupled to both vacuum source 16 and irrigation source 18through the use of switch valve 50, as is described in more detailbelow.

Bandage 14 promotes the healing of the wound by providing vacuum therapyto the wound to promote blood flow and remove exudate from the woundsurface and by providing for irrigation of the wound with fluids such assaline, for example. An illustrative wound treatment apparatus having awound temperature control system, a medicine delivery system, and adrainage system is disclosed in U.S. Pat. No. 6,458,109. An illustrativevacuum and irrigation system is disclosed in U.S. Patent Publication No.US 2002/0161317 A1. Additionally, an illustrative vacuum bandage isdisclosed in U.S. Patent Publication No. US 2002/0065494 A1. Alternativevacuum bandages are disclosed in U.S. Patent Publication No. US2002/0082567 A1. Further, a vacuum bandage system including a controllerof the system is disclosed in U.S. patent application Ser. No.10/159,583 filed on May 31, 2002, titled WOUND TREATMENT APPARATUS andin U.S. patent application Ser. No. 10/159,720 filed on May 31, 2002,titled WOUND TREATMENT APPARATUS. All of these applications are herebyincorporated herein by reference.

As mentioned above, system 10 incorporates two separate fluid lines toprovide vented vacuum therapy and vented irrigation therapy to thewound. Venting of bandage 14 is disclosed in U.S. Patent ApplicationSer. No. 60/344,588 filed on Dec. 26, 2001. This application is herebyincorporated herein by reference. Venting provides for increased airflow through bandage 14 and above or adjacent the wound while vacuumsource 16 applies suction to the wound. System 10 is also vented whileirrigation source 18 provides fluid to the wound. Without providing forventilation of the system 10 during operation of vacuum source 16, agenerally closed system is created between vacuum bandage 14 and vacuumsource 16. For example, in bandages without a ventilation system, oncethe requisite amount of air has been removed by the vacuum source 16 tocreate a predetermined negative pressure at the wound surface, it ispossible for the system to become generally static, inhibiting much, ifany, fluid flow from the wound surface. In some embodiments disclosedherein, static conditions may be created at the wound surface.

Ventilation of the system 10, while drawing a negative pressure over thewound, acts to prevent the system 10 from becoming static by drawing airin from the surrounding atmosphere through vent 19, to bandage 14 tocreate air flow above the wound, and out through a vacuum tube incommunication with vacuum source 14. Therefore, venting the system 10increases air flow above the wound while vacuum source 16 appliessuction to the wound.

The two fluid lines for ventilation and vacuum/irrigation of the woundare provided in multi-lumen tube 20, shown in cross-section in FIG. 4.As shown in FIG. 3, tube 20 is coupled to a connector 15 of bandage 14,and is therefore in communication with the wound at one end 21 and iscoupled to vent 19 at the other end 23. Tube 20 includes an inner lumen22 for selective communication with the vacuum source 16 and theirrigation source 18 and outer lumens 24 formed in a body or outer wall25 of tube 20 for communication with the surrounding atmosphere throughvent 19. Inner lumen 22 thus defines a portion of a vacuum/irrigationpassageway 42 and outer lumens 24 each define a portion of a ventilationpassageway 44.

As shown in FIG. 4, tube 20 includes four outer lumens 24 spaced aboutinner lumen 22. It is within the scope of this disclosure, however, toinclude a multi-lumen tube having one or more outer lumens incommunication with the surrounding atmosphere and one or more innerlumens in selective communication with the vacuum source 16 and theirrigation source 18. Illustratively, the outer diameter 26 of tube 20is 0.250 inch (6.300 mm), the inner diameter 28 of tube 20 (the diameterof inner lumen 22) is 0.125 inch (3.150 mm), and the diameter 29 of eachouter or peripheral lumen is 0.014 inch (0.353 mm). Although tube 20includes the above dimensions, it is within the scope of this disclosureto provide any suitable multi-lumen tube having lumens of any suitablesize.

As shown in FIG. 3, bandage 14 illustratively includes a thin, flexiblewound dressing member 12 having connector 15 coupled to tube 20 by abarbed tube coupler 11. Member 12 lies adjacent to and generallyconforms to the wound surface. Sealing film 13 is placed over member 12and sealed around tube 20 to the patient's healthy skin 27 surroundingthe wound, as shown in FIG. 1. Illustratively, connector 15 is incommunication with the wound by a plurality of passageways 66 of member12 and a plurality of holes 67, each in communication with one of thepassageways 66, formed in a bottom surface 68 of member 19. Tube coupler11 connects inner lumen 22 of tube 20 with connector 15. Each outerlumen 24 is open at an end 21 of tube 20. This allows air to be drawn infrom the atmosphere through vent 19, to flow through outer lumens 24 andexit tube 20 at end 21, to circulate around member 12 to the woundsurface, and to flow through the holes 67 and passageways 66 of member12 into a vacuum/irrigation passageway 42 formed in part by lumen 22.The negative pressure created by vacuum source 16 causes air to flowthrough system 10 in this manner.

Although bandage 14 is described above, it is within the scope of thisdisclosure for the system 10, and other alternative systems describedbelow, to include any suitable bandage or wound dressing member coupledto the vacuum source 16 to communicate negative pressure from the vacuumsource 16 to the wound. Bandage 14, therefore, is merely an illustrativebandage of the wound care bandage systems disclosed herein.

As mentioned above, system 10 further includes vent 19. Vent 19 iscoupled to end 23 of tube 20, as shown in FIG. 1, and is illustrativelyshown to be coupled to patient's healthy skin 27 by tape 94, forexample. As shown in FIGS. 2 and 3, vent 19 includes a multi-lumen orwound connector 30 for coupling with multi-lumen tube 20 and asingle-lumen connector 32 for coupling with single-lumen tube 52 or forcoupling directly to switch valve 50, as shown in FIG. 5. Vent 19further includes a filter 34, shown in phantom in FIGS. 2 and 3, housedwithin a filter housing 40. Multi-lumen connector 30 includes an innerconduit 36 and an outer conduit 38 concentric and coaxial with innerconduit 36 along an axis 39, as shown in FIG. 3. An edge 41 of innerconduit 36 is substantially coplanar with an edge 43 of outer conduit38. An annular space 45 is defined between a cylindrical inner surface47 of outer conduit 38 and a cylindrical outer surface 53 of innerconduit 36.

Inner conduit 36 is in communication with vacuum source 16 andirrigation source 18 through stopcock 50 and defines a portion of thevacuum/irrigation passageway 42. The vacuum/irrigation passageway 42extends through inner lumen 22, a portion of vent 19 and stopcock 50.Outer conduit 38, or annular space 45, is in communication with thesurrounding atmosphere and defines a portion of vent passageway 44. Thevent passageway 44 extends through outer lumens 24 and a portion of vent19 to the surrounding atmosphere.

As shown in FIG. 3, a ridge or stop 59 is coupled to inner surface 47 ofouter conduit 38 to prevent tube 20 from being inserted too far withinconnector 30 and thus sealing off outer lumens 24. Stop 59 prevents ventpassageway 44 from becoming closed off and keeps vent passageway 44 opento receive air from the surrounding atmosphere. Vent 19 includes threeevenly spaced stops 59 coupled to inner surface 47. It is within thescope of this disclosure, however, to include a vent having any numberof stops 59 or the like to prevent vent passageway 44 from becomingclosed off.

When connecting multi-lumen tube 20 with vent 19, inner conduit 36 isreceived within inner lumen 22 of tube 20. Wall 25 of tube 20, whichincludes outer lumens 24, is received within annular space 45 ofconnecter 30. Tube 20 is, therefore, press fit into connector 30 and, ifdesired, may be permanently coupled to connecter 30 through the use ofadhesives applied to the appropriate surfaces of connecter 30 and/ortube 20.

Connector 32 is received within single-lumen tube 52 when connectingvent 19 to tube 52. Tube 52 is press fit onto connector 32 so that anend 65 of single-lumen tube 52 abuts an annular shoulder surface 69 ofconduit 30. As noted above, vent 19 may also be coupled directly toswitch valve 50 through the use of a luer lock connection shown in FIG.5 and discussed further below.

As shown in FIG. 3, vent 19 includes an opening or passageway 46 leadingbetween outer conduit 38 and filter 34 to connect annular space 45 withthe surrounding atmosphere. Opening 46 extends radially away fromconduit 30 and is generally perpendicular to axis 39. Opening 46 isdefined by cylindrical wall 27. Illustratively, opening 46 has adiameter of 0.100 inch (2.54 mm), however, it is within the scope ofthis disclosure to include a vent having any suitably sized opening forreceiving air from the surrounding atmosphere.

Further illustratively, filter 34, is a 0.2 micron anti-microbial filterfor preventing bacteria and other microorganisms in the atmosphere fromentering the vent 19 and traveling along vent passageway 44 belowsealing film 13 of bandage 14 to the wound. Such an air filter, forexample, is made by W.L. Gore & Associates, Inc. of Elkton, Md. Asmentioned above, filter 34 is housed within housing 40. Housing 40 has acircular top wall 31, a cylindrical sidewall 33, and a circular bottomwall (not shown). Filter 34 is a generally circular dish of materialsandwiched between top wall 31 and the bottom wall. The bottom wall hasapertures, openings, or the like so that filter 34 is in communicationwith the surrounding atmosphere. Further, the bottom wall is removableso that filter 34 may be replaced if needed. Vent 19 further includesreinforcement ribs 35 appended to top wall 31 of housing 40 and wall 27defining passageway 46.

In operation, vent 19 is used during both vacuum and irrigation modes ofthe system. As mentioned before, vent 19 provides increased air flowthrough bandage 14 and above the wound. Vent 19 also creates an opensystem and prevents the system from becoming static. The air flow pathwhile vacuuming the system begins as air is drawn in from thesurrounding atmosphere into filter housing 40 of vent 19 and throughfilter 34. The air then travels through opening 46 into annular space 45defined by outer conduit 38 and through outer lumens 24 of multi-lumentube 20. The air travels through the outer lumens 24 from vent end 23 oftube 20 to end 21 of tube 20, a portion of which is positioned undersealing film 13, to communicate with the wound. Vacuum source 16 thendraws the air around wound dressing member 12 through passageways 66 atan open peripheral edge of member 12 and through holes 67 intopassageways 66. Air is then drawn from passageways 66 into connector 15of member 12, through barb 11, and through inner lumen 22 of multi-lumentube 20 toward vacuum source 14.

It is also within the scope of the disclosure for the caregiver to closeoff vent 19 while vacuuming or irrigating the wound. Vent 19 may beclosed in a number of ways. For example, a cap or valve (not shown) maybe coupled to filter 34 or filter housing 40 to prevent air flow throughfilter 40. It is within the scope of this disclosure to include a venthaving other suitable means of preventing air flow therethrough.

As shown in FIG. 3 and mentioned above, inner conduit 36 and outerconduit 38 form separate passageways through vent 19. Inner conduit 36is in communication with and forms a portion of vacuum/irrigationpassageway 42 which extends through inner lumen 22, a portion of vent 19and on to switch valve 50. Outer conduit 38 is in communication with andforms a portion of vent passageway 44, which extends through outerlumens 24 and a portion of vent 19. Vent passageway 44 is incommunication with the atmosphere through filter 34.

As shown in FIG. 1, system 10 further includes switch valve 50. Switchvalve 50 is positioned between vent 19 and vacuum and irrigation sources16, 18. Single-lumen tube 52 is coupled to and extends betweensingle-lumen connector 32 of vent 19 and switch valve 50 and forms aportion of vacuum/irrigation passageway 42. Switch valve 50, includes avent connector 54 which can be coupled either to single-lumen tube 52,as shown in FIG. 1, or directly to connecter 32 of vent 19, as shown inFIG. 5, through the use of a luer lock. Single-lumen connector 32includes a female thread portion 55 of the luer lock, and vent connector54 of switch valve 50 includes a male portion 57 of the luer lock sothat the two can be coupled together.

As shown in FIG. 5, switch valve 50 includes a body 60 and a handle ordiverter 51 coupled to body 60. Body 60 includes vent connector 54, avacuum connector 56 in communication with vacuum source 16, and anirrigation connector 58 in communication with irrigation source 18. Ventconnector 54 forms another portion of vacuum/irrigation passageway 42and is in selective communication with vacuum source 16 and irrigationsource 18. Vacuum/irrigation passageway 42 therefore extends from end 21of inner lumen 22 of multi-lumen tube 20 to multi-lumen connector 30 ofvent 19, through inner conduit 36 of vent 19, out connector 32 of vent19, to vent connector 54 of switch valve 50 and partially through switchvalve 50 to diverter 51 of switch valve 50.

Switch valve 50 includes diverter 51 for selectively providingcommunication between vacuum source 16 and bandage 14 and betweenirrigation source 18 and bandage 14. Diverter 51 includes a grip 62 anda stem 64 coupled to grip 62, as show in FIGS. 6 a and 6 b. Diverter 51is rotatably movable relative to body 60 to selectively providecommunication between either vent connector 54 and irrigation connector58 or between vent connector 54 and vacuum connector 56. A caregiverrotates diverter 51 between an irrigation position shown in FIG. 7 and avacuum position shown in FIG. 8 depending on whether the wound is toreceive vacuum or irrigation treatment, respectively. Switch valve 50allows the caregiver to easily switch between communication with vacuumsource 16 and irrigation source 18 without the need to disconnect orreconnect various tubes from each of the vacuum source 16 and/orirrigation source 18, for example.

As shown in FIGS. 7 and 8, body 60 includes an aperture 61 for receivingstem 64 of diverter 51. Vent connector 54, vacuum connector 56, andirrigation connector 58 each form a respective opening 82, 84, 86 incommunication with aperture 61. As diverter 51 is rotated, a cut-outportion 63 of stem 64 provides a passageway between vent connector 54and vacuum connector 56 when diverter 51 is in the vacuum position, forexample. When diverter 51 is in the irrigation position, cut-out portion63 provides a passageway between vent connector 54 and irrigationconnector 64. Diverter 51 is also movable to an off position wherecut-out portion 63 does not provide any communication between theconnectors 54, 56, 58.

In addition to vacuum/irrigation passageway 42 and vent passageway 44,system 10 further includes a separate vacuum passageway 70 and aseparate irrigation passageway 72. Vacuum connector 56 defines a portionof vacuum passageway 70 and irrigation connector 58 defines a portion ofirrigation passageway 72. As shown in FIG. 1, vacuum connector 56 iscoupled to a vacuum tube 74 which is, in turn, coupled to vacuum source16. The vacuum passageway 70, therefore, extends from opening 84 of body60 through vacuum connector 56 and vacuum tube 74 to vacuum source 16.

As shown in FIG. 1, irrigation connector 58 is coupled to an irrigationtube 76 which is, in turn, coupled to irrigation source 18. Theirrigation passageway 72, therefore, extends from opening 86 of body 60through irrigation connector 58 and irrigation tube 76 to irrigationsource 18. Thus, at opening 82 of body 60, vacuum/irrigation passageway42 ends and is split into separate vacuum and irrigation passageways 70,72.

As shown in FIG. 5, an attachment 88 is coupled to irrigation connector58. Attachment 88 includes a first inlet 90 for communication withirrigation tube 76 and irrigation source 18 and a second inlet 92 forcommunication with a hand-held syringe (not shown). Attachment 88provides two means of introducing fluids into system 10. Second inlet 92allows a caregiver to manually introduce fluids into system 10 whileirrigation source 18 includes automatic controls for introducing fluidsinto system 10 through first inlet 90. A slot 96 of irrigation connector58 receives a portion of second inlet 92 to secure attachment 88 withinirrigation connector 58.

As mentioned above, system 10 allows a caregiver to treat the woundusing vented vacuum therapy through the use of vent 19 with vacuumsource 16 and using vented irrigation therapy through the use ofirrigation source 18 and vent 19. To provide vented vacuum therapy tothe wound, the caregiver moves diverter 51 to the vacuum position, shownin FIG. 8, so that cut-out portion 63 of stem 64 connects opening 82 ofvent connector 54 with opening 84 of vacuum connector 56. Therefore,irrigation connector 58 and irrigation passageway 72 are closed off andvacuum/irrigation passageway 42 is connected with vacuum connector 56and vacuum passageway 70. Vent passageway 44 is kept open to thesurrounding atmosphere. The negative pressure provided by vacuum source16 above wound 12 acts to draw air in from the atmosphere through filter34 of vent 19 and outer lumens 24. As mentioned above, vent 19 isprovided to aspirate the system 10 by creating an air flow path from theatmosphere to the bandage 14, over the wound, and out through innerlumen 22 in communication with vacuum source 16.

To create vented irrigation of wound 12, a caregiver moves diverter 51to the irrigation position so that cut-out portion 63 of stem 64connects opening 82 of vent connector 54 with opening 56 of irrigationconnector 58. Therefore, irrigation passageway 72 of the irrigationconnector 58 is in communication with the vacuum/irrigation passageway42 of the vent connector 54. The vacuum passageway 70 is thus cut offfrom communication with the vacuum/irrigation passageway 42. Irrigationfluid is then dispensed from irrigation source 18 through irrigationpassageway 72 of tube 76 and switch valve 50 to the vacuum/irrigationpassageway 42 through vent connector 54, tube 52, vent 19, and innerlumen 22 of multi-lumen tube 20 to wound 12. Vent 19 is left in an openposition to allow air to flow out of bandage 14 while fluid fromirrigation source 18 is channeled to the wound. As mentioned above, itis also within the scope of this disclosure to provide non-ventedirrigation of the wound by closing off vent 19 from the surroundingatmosphere while providing fluid to the wound through irrigation source18.

As mentioned above, the combination of vent 19, and switch valve 50 isdefined as vent-valve assembly 80. If desired, assembly 80 may alsoinclude tube 52 or another conduit or passageway between vent 19 andswitch valve 50. Assembly 80 provides a caregiver with the ability totoggle or selectively switch between the vented vacuum mode of therapyand the vented irrigation mode of therapy for the treatment of thewound. As mentioned above, it is within the scope of this disclosure toinclude a vent which is able to be closed off from communication withthe surrounding atmosphere so that vacuum only and/or irrigation onlytherapy may be provided as well.

An alternative vent-valve assembly 180 is provided for use with system10, as shown in FIGS. 9-16. Assembly 180 includes a stopcock or valveportion in selective communication with vacuum source 16 and irrigationsource 18 and a vent portion in communication with the surroundingatmosphere. Assembly 180 is configured to selectively provide threemodes of therapy: vacuum therapy, vented vacuum therapy, and ventedirrigation therapy.

As shown in FIG. 9, vent-valve assembly 180 is positioned betweenillustrative bandage 14 of system 10 and vacuum and irrigation sources16, 18. Assembly 180 serves a similar function as assembly 80, includingvent 19 and stopcock 50, shown in FIGS. 1-8. Similar to assembly 80,assembly 180 is in communication with bandage 14, vacuum source 16, andirrigation source 18 of system 10. Assembly 180 is operated by acaregiver during the treatment of a patient to change from mode to modeas desired.

As shown in FIG. 10, assembly 180 includes an outer shell or body 110and a diverter or inner barrel 112. Inner barrel 112 is normallypositioned within outer shell 110, as shown in FIG. 9, and is rotatablerelative to outer shell 110 between three different positions whichcorrelate with the three available modes: vacuum, vented vacuum, ventedirrigation. Outer shell 110 includes a cylindrical hub 114 having anouter surface 116 and in inner surface 118, shown in FIG. 10. Outershell 110 further includes a multi-lumen or wound connector 130, a vent119, a vacuum connector 156, and an irrigation connector 158. Suitablecoupling means such as a C-clip (not shown) to fit around inner barrel112, a pin (not shown) through outer shell 110 and inner barrel 112, forexample, are provided to prevent inner barrel or diverter 112 from beinginadvertently separated from body 110. Such coupling-means are alsoprovided for use with stopcocks 50 and 250 (discussed below) to preventthe handle of each from being inadvertently decoupled from the body ofeach.

Similar to multi-lumen connector 30 of vent 19, multi-lumen connector130 of assembly 180 includes inner conduit 36 and outer conduit 38spaced apart from and concentric with inner conduit 36. Inner conduit 36defines a portion of vacuum/irrigation passageway 42 and outer conduit38 defines a portion of vent passageway 44 of system 10. Inner conduit36 is received within inner lumen 22 of tube 20. Wall 25 of tube 20,which includes outer lumens 24, is received within outer conduit 38 ofmulti-lumen connector 130. As shown in FIG. 9, inner conduit 36 iscoupled to a barb 37. Barb 37 is received within inner lumen 22 as welland helps maintain the connection between tube 20 and multi-lumenconnector 130. It is within the scope of this disclosure for multi-lumenconnector 30 of vent 19 to have barb 37 formed integrally with innerconduit 36.

As shown in FIG. 10, outer conduit 38 includes a partition 48 havingmultiple vent holes 49 formed therethrough. Air traveling through lumens24 also travels through the holes 49 to a vent grove 122 formed in innersurface 118 of hub 114. It is not necessary for outer lumens 24 of tube20 to align directly with one of the vent holes 49. A stop (not shown),similar to stop 59, is coupled to inner surface 47 of outer conduit 38to prevent tube 20 from being inserted too far within connecter 130.Vent groove 122 connects outer conduit 38 with vent 119, as is describedin more detail below.

Vacuum connector 156 communicates with vacuum source 16 through vacuumtube 74. Vacuum connector 156 includes barb 37 received within tube 74.Vacuum connector 156 and vacuum tube 74 form vacuum passageway 70 ofsystem 10. Irrigation connector 158 communicates with irrigation source18 through irrigation tube 76, as shown in FIG. 17. Irrigation connector158 and irrigation tube 76 form the irrigation passageway 72 of system10. Vacuum connector 156 and irrigation connector 158 are each inselective communication with multi-lumen connector 130, as is describedbelow. As shown in FIG. 9, air filter 34, contained within a housing124, is coupled to vent 119 and is received within an aperture 120(shown in FIG. 10) of vent 119. Housing 124 includes an air inlet tube126 and a connector tube 128 coupled to vent 119 and in communicationwith aperture 120 of vent 119.

Diverter 112, as shown in FIG. 10, includes a grip 162 and a cylinder orstem 164 coupled to grip 162. Cylinder 164 includes an upper level ofholes and a lower level of holes, as shown in FIG. 10. As shown inphantom in FIGS. 11, 13, and 15, the upper level of holes includesfirst, second, third, fourth, and fifth holes 166, 168, 170, 172, 174,respectively. As shown in FIGS. 12, 14, and 16, the lower level of holesincludes first, second, third, and fourth holes 182, 184, 186, and 188,respectively. The upper level of holes communicate with inner conduit 36of multi-lumen connector 130 and with each of the vacuum and irrigationconnectors 156, 158. The lower level of holes communicate with outerconduit 38 and aperture 120 of vent 119. The upper holes of cylinder 164form interconnecting passageways through cylinder 164 to selectivelyconnect inner conduit 36 with vacuum conduit 156 and irrigation conduit158 and the lower holes form passageways through cylinder 164 toselectively connect outer conduit 38 with vent 119, as is described inmore detail below.

As shown in FIGS. 11 and 12, assembly 180 is in the vented vacuumposition. As shown in FIG. 11, the upper holes are positioned so thathole 166 is in communication with inner conduit 36 and hole 170 is incommunication with vacuum connector 156 to provide a passageway betweeninner conduit 36 and vacuum connector 156. The other holes 168, 172 and174 are not in communication with any of the connectors 130, 156, 158 ofouter shell 110. Looking now to the lower level of holes shown in FIG.12, hole 182 is in communication with vent groove 122 and hole 186 is incommunication with aperture 120 of vent 119 to provide a passagewaybetween vent groove 122 and vent 119 so that outer lumens 24 of tube 20are in communication with the surrounding atmosphere.

By rotating grip 162 clockwise (as viewed from the top of apparatus180), a caregiver rotates inner barrel 112 relative to outer shell 110to move assembly 180 to the vacuum position shown in FIGS. 13 and 14. Inthe vacuum position, upper level hole 174 is in communication with innerconduit 36 of multi-lumen connector 130 and hole 168 is in communicationwith vacuum connector 156 to provide a passageway between inner conduit36 and vacuum connector 156. In the vacuum position, however, ventpassageway 44 of system 10 is prevented from communicating with thesurrounding atmosphere through vent 119. As shown in FIG. 14, forexample, none of the lower level holes are in communication with eithervent groove 122 or aperture 120 of vent 119.

By rotating grip 162 still further clockwise, a caregiver rotates innerbarrel 112 relative to outer shell 110 to move assembly 180 to thevented irrigation position shown in FIGS. 15 and 16. FIG. 15 shows theorientation of the upper level holes of the inner barrel 112 whileassembly 180 is in the vented irrigation position. Hole 172 is incommunication with inner conduit 36 of multi-lumen connector 130 andhole 166 is in communication with irrigation connector 158 to providecommunication between inner conduit 36 and irrigation connector 158.FIG. 16 shows the orientation of the lower level holes when stopcock 180is in the vented irrigation position. Hole 188 is in communication withvent groove 122 and hole 184 is in communication with aperture 120 ofvent 119 so that outer conduit 38 is in communication with vent 119 toallow air from the surrounding atmosphere to enter system 10. It is alsowithin the scope of this disclosure for assembly 180 to be in an “off”position where none of the upper level passageways connect any of theconnecters 130, 158, 156 with each other, and where none of the lowerlevel passageways connect the vent grove 122 with the vent 119.

Referring now to FIGS. 17-19, a tube coupler 140 is provided for usewith system 10. As shown in FIG. 17, coupler 140 is positioned betweenbandage 14 and assembly 180. It is within the scope of this disclosure,however, to position a tube coupler between bandage 14 and assembly 80shown in FIG. 1. Coupler 140 connects or couples two multi-lumen tubestogether. Coupler 140 allows a caregiver to disconnect a portion ofsystem 10 between bandage 14 and assemblies 80 or 180. As shown in FIGS.17-19, coupler 140 couples multi-lumen tube 20 to another multi-lumentube 17.

Coupler 140 includes an outer body 142 having a curved upper surface 144and a generally flat bottom surface 146. Outer body 142 defines apassageway 148 therethrough for receiving a portion of a multi-lumentube at a first end 136 and at a second end 138. Passageway 148 isdefined by an inner surface 149 of body 142. Coupler 140 furtherincludes an inner conduit 150 which defines a portion ofvacuum/irrigation passageway 42. Inner conduit 150 is positioned withinpassageway 148. A portion of vent passageway 44 is annular and isdefined between inner surface 149 of body 142 and an outer surface 151of inner conduit 150. Coupler 140 further includes a central partition152 formed around conduit 150 and connected to inner surface 149.Partition 152 includes three generally evenly spaced holes 154 for thevented air to flow through.

An end of tube 20 is inserted into first end 136 of coupler 140 and anend of tube 17 is inserted into second end 138 of coupler 140, as shownin FIG. 19, so that inner conduit 150 is received within the inner lumen22 of each tube 20, 17. As mentioned above, multi-lumen tubes 20, 17include four outer lumens 24 formed in wall 25. As shown in FIG. 19,tubes 20, 17 are inserted into coupler 140 and are generallyspaced-apart from partition 152 so that air flowing through the fourouter lumens 24 of tube 17 flows into an open space 155 on the rightside of partition 152, as shown in FIG. 19, through holes 154 ofpartition 152 and into an open space 157 located on the left side ofpartition 152 into outer lumens 24 of tube 20.

Tube coupler 140 may also be used to aide in effectively securingsealing film 13 of bandage 14 over or around tube 20. For example,coupler 140 may be placed on the patient's healthy skin adjacent thewound. The film 13 may then be placed over curved upper surface 144 ofcoupler 140 and effect a seal around coupler 140 to create a sealedenvironment between film 13 and the wound. Coupler 140, therefore, mayalso act to prevent leaks in the vacuum space created below film 13.Coupler 140 further includes a ridge or stop 153 coupled to innersurface 149 to each of the right and left sides of partition 152 toprevent each respective tube 20, 17 from abutting partition 152 andclosing off vent lumens 24 from communication with the surroundingatmosphere. Each open space 155, 157, therefore, is defined between arespective stop 153 and partition 152, as shown in FIG. 19.

Referring now to FIGS. 20-28, another illustrative wound care bandagesystem 210 is provided. System 210 operates similarly to system 10described above and includes a vent-valve apparatus 280 to provideventilation while allowing a user to toggle between a vacuum therapymode and an irrigation therapy mode. As shown in FIG. 20, bandage 14 iscoupled to a vent 219 via an alternative multi-lumen tube 220.Specifically, member 12 of bandage 14 is coupled to a “Y-connector” 212of the system 210 which is coupled to tube 220. Y-connector 212 is shownin more detail in FIGS. 22 and 24 and is discussed in more detail below.

Vent-valve apparatus 280 includes a stopcock or switch valve 250 coupledto vent 219 via two single-lumen tubes 216, 218. Switch valve 250 iscoupled to both vacuum source 16 and irrigation source 18 to provideselective communication between either the bandage 14 and vacuum source16 or between bandage 14 and irrigation source 18, as described below.

Vent 219, similar to vent 19, is spaced apart from bandage 14 and isillustratively shown to be coupled to patient's healthy skin 27 by tape94, for example. Vent 219 is able to provide ventilation to wound 200(shown in FIG. 20) during the application of negative pressure to wound200 and during irrigation of wound 200 because vent 219, similar tovents 19 and 119 are in communication with the surrounding atmosphereand with the wound 200.

The wound care bandage system 21-0 shown in FIGS. 20-28 incorporatesthree separate fluid paths. One fluid path is used exclusively for thepurpose of venting the wound 200 with air from the surroundingatmosphere. A second fluid path is used to create a negative pressureadjacent the wound 200, while the third fluid path is used to irrigatethe wound 200. Switch valve 250 acts to selectively communicate eitherthe vacuum path or the irrigation path with the wound 200. The threefluid paths for ventilation, vacuum, and irrigation of wound 200 areprovided by multi-lumen tube 220.

Multi-lumen tube 220 includes a vacuum lumen 222, an irrigation lumen224, and four outer venting lumens 226 formed within and defined by abody 228, as shown in FIG. 21. Vacuum lumen 222 is in communication withvacuum source 16, irrigation lumen 224 is in communication withirrigation source 18, and each venting lumen 226 is in communicationwith the atmosphere through vent 219, as is described below. As shown inFIGS. 20 and 24, multi-lumen tube 220 is coupled to an alternativeconnector 214 of member 12 by Y-connecter 212, and is therefore incommunication with the wound 200 at one end 230 and is coupled to vent260 at another end 232.

Although tube 200 is shown to include four venting lumens 214, it iswithin the scope of this disclosure to include a multi-lumen tube havingone or more venting lumens in communication with the surroundingatmosphere, one or more vacuum lumens in communication with the vacuumsource 16, and one or more irrigation lumens in communication with theirrigation source 18. Illustratively, an outer diameter 234 of tube 220is 0.375 inch (9.53 mm), a diameter 236 of vacuum lumen 222 is 0.125inch (3.175 mm), a diameter 238 of irrigation lumen 224 is 0.125 inch(3.175 mm), and a diameter 240 of each outer venting lumen 226 is 0.020inch (0.508 mm). Although tube 220 includes the above dimensions, it iswithin the scope of this disclosure to provide any suitable multi-lumentube having lumens of any suitable size.

As mentioned above, Y-connecter 212 is provided for coupling withalternative connector 214 of vacuum bandage 14. Connector 214 is similarto connector 15 and is in communication with wound 200 through channels66 and holes 67 of member 12. Connector 214 is different from connector15 in that connector 214 is positioned at an angle relative to a topsurface 242 of member 12 and includes a single angled passageway 244 (asshown in FIG. 24) rather than a vertical passageway connected to ahorizontal passageway of connector 15 (as shown in FIG. 3). In theillustrative embodiment, the included angle between an axis alongpassageway 244 and the top surface 242 of member 12, when member 12 isin a flat configuration, is about 30 degrees.

Illustratively, Y-connecter 212 includes a bandage portion 246, anirrigation portion 248, and a vacuum portion 252, as shown in FIG. 22.Irrigation portion 248 includes a passageway 254 forming a section ofthe irrigation passageway, vacuum portion 252 includes a passageway 256forming a section of the vacuum passageway, and bandage portion 246includes a passageway 258 forming a section of the vacuum/irrigationpassageway. The passageway 254 of irrigation portion 248 and thepassageway 256 of vacuum portion 252 each merge into passageway 258 ofthe bandage portion 246. Once bandage portion 246 of Y-connecter 212splits into the irrigation portion 248 and the vacuum portion 252, theirrigation and vacuum passageways remain separate and distinctpassageways through multi-lumen tube 220, vent 219, and switch valve 250to the respective irrigation source 18 and vacuum source 16.

Bandage portion 246 is press fit into connector 214, as shown in FIG.24, and includes an angled end 260 to lie adjacent to the top surface242 of member 12. Irrigation portion 248 is similarly press fit intoirrigation lumen 224 of tube 220 and vacuum portion 252 is press fitinto vacuum lumen 222 of tube 220. In some embodiments, adhesive orsealant is applied to either or all of portions 246, 248, 252 to furtherenhance the connection between bandage portion 246 and connector 214between irrigation portion 248 and tube 220, and between vacuum portion252 and tube 220. Y-connecter 212 is provided to connect bandage 14 withmulti-lumen tube 220 and vent 219.

Referring now to FIG. 23, vent 219 includes a multi-lumen connector 262for coupling with multi-lumen tube 220, a single-lumen vacuum connector264 for coupling with a single-lumen tube, such as tube 216, and asingle-lumen irrigation connector 266 for coupling with a single-lumentube, such as tube 218 (as shown in FIG. 20). Tubes 216 and 218 are alsocoupled to switch valve 250 as shown in FIG. 20 and described in moredetail below. It is also within the scope of this disclosure toeliminate the use of tubes 216 and 218 so that vent 219 is coupleddirectly to switch valve 250. Similar to vents 19, 119, vent 219 furtherincludes filter 34 (shown in phantom), housed within filter housing 40,in communication with multi-lumen connector 262.

Multi-lumen connector 262 includes an outer conduit 272, an inner vacuumconduit 274, and an inner irrigation conduit 276, as shown in FIG. 23.Both vacuum conduit 274 and irrigation conduit 276 are located withinouter conduit 272. An edge 278 of outer conduit 272 is substantiallycoplanar with an edge 281 of vacuum conduit 274 and an edge 282 ofirrigation conduit 276. Vacuum conduit 274 is in communication withvacuum source 16 through switch valve 250 and defines a portion of thevacuum passageway. Irrigation conduit 276 is in communication with theirrigation source 18 through switch valve 250 and defines a portion ofthe irrigation passageway. Outer conduit 252 is in communication withthe surrounding atmosphere and defines a portion of the vent passageway.

As shown in FIG. 24, vacuum conduit 274 is received within vacuum lumen222 of tube 220. Body 228 of tube 220, which includes outer ventinglumens 226, is received within a space 284 defined between a cylindricalinner surface 286 of outer conduit 272 and cylindrical outer surfaces288, 290 of vacuum and irrigation conduits 274, 276, respectively (asshown in FIG. 23). Tube 220 is press fit into the space 284 so that theouter surface of tube 220 abuts cylindrical inner surface 286 of outerconduit 272, so that an inner surface of vacuum lumen 220 abuts thecylindrical outer surface 288 of the vacuum conduit 274, and so that theinner surface of irrigation lumen 224 abuts the cylindrical outersurface 290 of the irrigation conduit 276. In some embodiments, anadhesive material or sealant is applied to the appropriate surfaces oftube 220 and multi-lumen connector 262 to enhance the connection betweentube 220 and vent 219.

As shown in FIG. 23, a ridge or stop (not shown) is coupled to andpositioned between outer surface 288 of vacuum conduit 274 and outersurface 290 of irrigation conduit 276 to prevent tube 220 from beinginserted too far within connector 262 and thus sealing off outer lumens226. The stop prevents vent passageway from becoming closed off andkeeps vent passageway open to receive air from the surroundingatmosphere. Illustratively, vent 219 includes one stop, however, it iswithin the scope of this disclosure to include a vent having any numberof stops or the like to prevent the vent passageway from becoming closedoff from the surrounding atmosphere.

Vacuum connector 264 of vent 219 includes an inner surface 292 defininga portion of the vacuum passageway and an outer surface 294. Vacuumconnector 264 is in communication with vacuum conduit 274 of multi-lumenconnector 262, as shown in phantom in FIGS. 23 and 24. Illustratively,single-lumen tube 216, coupled to vacuum source 16, is press fit intovacuum connector 264, as shown in FIG. 24. Tube 216 may further bepermanently or temporarily bonded to vacuum connecter 264 through theuse of an adhesive material applied to the appropriate surfaces of tube216 and connecter 264.

Irrigation connector 266 of vent 219 similarly includes an inner surface296 defining a portion of the irrigation passageway and an outer surface298 including a shoulder 300. Irrigation connector 266 is incommunication with irrigation conduit 276 of multi-lumen connector 262,also shown in FIGS. 23 and 24. Illustratively, single-lumen tube 218 ispress-fit into irrigation connector 266, as shown in FIG. 24. Tube 218may further be permanently or temporarily bonded to irrigation connector266 through the use of an adhesive material applied to the appropriatesurfaces of tube 218 and connector 266. It is within the scope of thisdisclosure, however, to connect tubes 216 and 218 to the respectiveirrigation and vacuum connectors 266, 264 through the use of a barb or aluer lock connection, for example.

Outer conduit 272 of multi-lumen connector 262 further includes anopening or aperture 302 in communication with the surroundingatmosphere. Housing 40 for filter 34 is coupled to multi-lumen connector262 so that a passageway 46 of housing 40 connects space 284 with thefilter 34 and the surrounding atmosphere. Passageway 46 extends radiallyaway from outer conduit 272 and is generally perpendicular to an axisrunning through vacuum conduit 274. Passageway 46 is defined bycylindrical wall 27.

In operation, vent 219 is used during both vacuum and irrigation modesof the system. As mentioned before with respect to vents 19 and 119,vent 219 provides increased air flow through bandage 14 and above wound200. Vent 219 also creates an open system and prevents the system frombecoming static. Vent 219 further maintains separate vacuum andirrigation passageways. As mentioned before with respect to vents 19,119, it is within the scope of the disclosure for the caregiver to closeoff vent 160 while vacuuming or irrigating wound 200. Vent 219 may alsobe closed in a number of ways. For example, a cap or a valve (not shown)may be coupled to filter 34 or filter housing 40 to prevent air flowthrough filter 34. It is within the scope of this disclosure to includea vent having other suitable means of preventing air flow therethrough.

Referring now to FIGS. 25-28, the stopcock 250 of system 210 includes adiverter or handle 314 and a body 316 defining an aperture 318 forreceiving at least a portion of the handle 314. Handle 314 includes agrip 320 and a hub or stem 322 coupled to the grip 320. Hub 322 isreceived within aperture 318 of body 316. Stopcock or switch valve 250further includes a vacuum conduit 310 having a first portion 324 coupledto tube 216 and a second portion 326 coupled to a single-lumen tube 328,as shown in FIG. 20. Tube 328, is coupled to vacuum source 16, as shownin FIG. 20. As shown in FIGS. 25-28, vacuum conduit 310 defines aportion of the vacuum passageway through body 316. Each single-lumentube 216, 328 is coupled to the respective first portion 324 and secondportion 326 of the stopcock 250 through the use of luer locks (notshown). It is within the scope of this disclosure, however, to connecttubes 216, 328 to stopcock 250 in another suitable manner such asthrough the use of a barb, by press-fitting each tube 216, 328 ontoconduit 310 of stopcock 250, or by slip-fitting each tube 216, 328 intoconduit 310, and including the use of adhesive material to permanentlyor temporarily bond each tube 216, 328 to conduit 310.

Stopcock 250 further includes an irrigation conduit 330 having a firstportion 332 coupled to tube 218 and a second portion 334 coupled to asingle-lumen tube 336. Tube 336 is coupled to irrigation source 18, asshown in FIG. 20. Irrigation conduit 330 defines a portion of theirrigation passageway through body 316 of stopcock 250. As shown in FIG.25, irrigation conduit 330 lies below vacuum conduit 310 as indicated bya distance 311 so that the irrigation conduit 330 and vacuum conduit 310are positioned to lie in separate horizontal planes. Tubes 218, 336 maybe coupled to irrigation conduit 330 by the same or similar means asthose discussed above with respect to tubes 216, 328 and vacuum conduit310.

Hub 322 of handle 314 includes a first or vacuum cut-out portion 340 anda second or irrigation cut-out portion 342. Similar to conduits 310 and330, cut-out portions 340, 342 do not lie in the same horizontal plane.When hub 322 is received within aperture 318 of body 316, vacuum cut-outportion 340 lies in the same horizontal plane as vacuum conduit 310 andirrigation cut-out portion 342 lies in the same horizontal plane asirrigation conduit 330.

Handle 314, and thus hub 322, is rotatable relative to body 316. Handle314 is able to be positioned by a caregiver to align the vacuum cut-outportion 340 with the vacuum conduit 310, as shown in FIG. 26, or toalign the irrigation cut-out portion 342 with the irrigation conduit330, as shown in FIG. 27. Further, handle 314 may be rotated to an “off”position where neither cut-out portion 340, 342 is aligned with eitherof the conduits 310, 330, as shown in FIG. 28. Thus, passageways 344,346 through conduits 310, 330 each communicate with aperture 318 of body316.

Referring to FIG. 26, the stopcock 250 is in a vacuum position wherevacuum cut-out portion 340 is aligned with vacuum conduit 310, asmentioned above. Vacuum cut-out portion 340 connects first portion 324of vacuum conduit 310 with second 326 of vacuum conduit 310 so thatvacuum source 16 is able to create a negative pressure adjacent thewound 200. When stopcock 250 is in the vacuum position, irrigationcut-out portion 342 is not in communication with the irrigation conduit330.

Rotating handle 314 about 90 degrees clockwise from the vacuum positionaligns irrigation cut-out portion 342 with irrigation conduit 330 in anirrigation position shown in phantom in FIG. 27. Irrigation cut-outportion 342 connects first end 332 of irrigation conduit 330 with secondend 334 of irrigation conduit 330 so that the irrigation source 18 isable to send fluids through stopcock 250 to wound 200. When stopcock 250is in the irrigation position, vacuum cut-out portion 340 is not incommunication with the vacuum conduit 310.

To move the stopcock 250 to the “off” position (shown in FIG. 28), thecaregiver may either rotate the handle 180 degrees in either directionfrom the irrigation position (shown in FIG. 27) or the caregiver mayrotate the handle 90 degrees in the counter-clockwise direction from thevacuum position (shown in FIG. 26). As mentioned above, neither cut-outportion 340, 342 communicates with either conduit 310, 330 when stopcock250 is in the “off” position.

As shown in FIG. 25, grip 320 of handle 314 includes an indicator 350 toindicate to the caregiver whether the stopcock 250 is in the vacuumposition, irrigation position, or off position. It is within the scopeof this disclosure to include a seal, gasket, or o-ring (not shown)between hub 322 and body 316 of stopcock 250 to create a seal betweenthe two components.

Looking now to FIGS. 29 and 30, yet another wound care bandage system400 is provided which has the capability to create negative pressureadjacent wound 200, to irrigate wound 200, and to ventilate wound 200.Ventilated vacuum bandage system 400 is provided for use with wound 200having a wound surface 413. The system 400 includes a wound dressingmember 419 similar to wound dressing member 12, shown in FIG. 24, avacuum source 16, an irrigation source 18, and a vent 460 incommunication with the member 419. The vent 460 is also in communicationwith the surrounding atmosphere to provide increased air flow above thewound surface 413 and through the member 419 particularly when thevacuum source 16 is operating to create a negative pressure above thewound 200. As is herein defined with respect to all embodimentsdisclosed herein, the term “vent” is or includes any passageway to theatmosphere, unless noted otherwise.

In one illustrative embodiment, a vacuum bandage 410 is provided for usewith wound 200 having wound surface 413, shown in FIG. 30. Bandage 410includes the wound dressing member 419 and a vent 460 in communicationwith member 419 as shown in FIGS. 29 and 30. Member 419 isillustratively thin and flexible and includes a wound contacting layer420 and a cover 422 coupled to the layer 420. Member 419 also includes aconnector 423 coupled to cover 422 for communication with vacuum source16 and/or irrigation source 18.

Vacuum bandage 410 is coupled to vacuum source 16 and irrigation source18 through the use of a switch valve 455, as shown diagrammatically inFIG. 29. Switch valve 455 may be the same as or similar to stopcock 50and/or assemblies 80, 180, described above, for example. Similar tobandage 14, bandage 410 also promotes the healing of large wound 200 byproviding vacuum therapy to the wound 200 to promote blood flow andremove exudate from wound surface 413 and by providing for irrigation ofthe wound 200 with fluids such as saline, for example.

Vent 460 of system 400 is provided for increased air flow throughbandage 410 and above wound 200 while vacuum source 16 applies suctionto wound 200. Without vent 460, a generally closed system is createdbetween vacuum bandage 10 and vacuum source 14. Vent 460, similar tovents 19, 119, 219 discussed above, acts to prevent the system 400 frombecoming static by drawing air in from the surrounding atmosphere aroundbandage 410. Air is drawn through vent 460 to bandage 410 to createairflow above wound 200, through member 419, and out through a vacuumtube 441 coupled to vacuum source 16. A wound care technique disclosingventilation of the wound is provided in the article “No wound is too bigfor resourceful nurses” by Margaret Wooding-Scott, RN, CCRN, Barbara AnnMontgomery, RN, ET, and Deborah Coleman, RN, MS, CS as published in theDecember 1988 edition of the magazine RN.

Referring now to member 419, layer 420, cover 422, and connecter 423 areeach made of a medical grade silicone or other type of pliableelastomer. Two companies, for example, which manufacture such medicalgrade silicone are GE Silicones and NuSil Technology. It is within thescope of this disclosure, however, to include a member made of anysuitable type of material. Illustratively, member 419 is made ofmaterial that is non-porous and non-foam-like. This thin, flexiblematerial is also generally non-absorptive. For example, materials suchas polyvinylchloride (PVC), PVC free of diethylhexyl phthalate(DEHP-free PVC), polyurethane, or polyethylene may be used in themanufacture of member 419. However, as mentioned above, it is within thescope of this disclosure to include a bandage having a member made ofany suitable material to communicate the negative pressure from thevacuum source to the wound. Further, layer 420, cover 422, and connecter423 may each be molded to include anti-microbial constituents. Forexample, it is within the scope of this disclosure to impregnate member419 with silver ions which are known anti-microbials.

Illustratively, member 419, including layer 420, cover 422, andconnecter 423, is also made of a generally non-adhesive material.Therefore, wound contacting layer 420, which lies generally adjacent tothe wound surface 413, does not adhere to the wound surface 413.Further, member 419 is illustratively solid in nature and generallynon-compressible. Member 419 is also illustratively transparent.Therefore, a caregiver or user is able to see the wound 200 throughmember 419 when member 419 is placed adjacent to wound surface 413. Thistransparency allows the caregiver to view the progress of the healing ofthe wound 200.

Layer 420 includes a wound facing surface 424 and an upper or oppositesurface 426. Wound facing surface 424, or portions thereof, contact andconform to the wound surface 413. Opposite surface 426 includes acentral area 428 and a plurality of channels 430 spaced-apart from andextending radially away from central area 428. Central area 428 isrecessed relative to the portions of upper surface 426 between channels430. As shown in FIG. 29, channels 430 are open at the sides and ends ofmember 419. Opposite surface 426 further includes concentric channels431. Illustratively, each channel 430, 431 is 0.030 inch (0.762 mm) wideand 0.030 inch (0.762 mm) deep. It is within the scope of thisdisclosure, however, to include channels 430, 431 of opposite surface426 having other suitable widths and depths suitable for the presentapplication. Central area 428 of layer 420 is provided to communicatewith the vacuum source 16 and irrigation source 18 through a port 440 ofcover 422, as will be described below.

Illustratively, a plurality of radially extending protrusions or bosses432 are positioned around central area 428. Bosses 432 are positionedbetween central area 428 and channels 430, 431, as shown in FIG. 29.Bosses 432 are provided to prevent central area 428 from collapsing inon port 440 of cover 422 to form a seal and effectively block air flowthrough port 440 while suction is applied to the bandage 410. Port 440communicates with the vacuum source 16 and/or the irrigation source 18via connecter 423 and tube 441, as shown in FIGS. 29 and 30. Tube 441 iscoupled to connecter 423 by a barbed tube coupler 498, similar to tubecoupler 11 described above. Tube 441 may also be coupled directly toconnecter 423.

As mentioned above, port 440 is in communication with central area 428of layer 420. Illustratively, four bosses 432 are shown in FIG. 29.However, it is within the scope of this disclosure to provide any numberof bosses 423 or the like around central area 428 of layer 420 toprevent central area 428 from sealing off port 440 of cover 422 assuction is applied to bandage 410. Further, it is within the scope ofthis disclosure to include a boss or bosses having any shape in order toprevent central area 428 from sealing off port 440 when vacuum source 16is running.

Connecter 423, as shown in FIGS. 29 and 30 is a tubal port coupled to atop surface 436 of cover 422 and in communication with port 440 of cover422. As mentioned before, it is within the scope of this disclosure forconnector 423 to be a separate component of member 419 which is coupledto cover 422 or for connecter 423 to be coupled to cover 422 by beingmolded integrally with cover 422. Connector 423 includes a passagewayformed at a right-angle. Thus, the passageway in connecter 423 has avertical portion 425 that communicates with port 440 and a horizontalportion 427 that communicates with vertical portion 425. Connector 423connects with tube 441 through the coupler 498 to provide a horizontaltube attachment for tube 441. Cover 422 includes a bottom surface 434and top surface 436, as shown in FIG. 29. Bottom surface 434 engagesopposite surface 426 of layer 420, as shown in FIG. 30.

In some embodiments, member 419 is formed by heat sealing oppositesurface 426 of layer 420 and bottom surface 434 of cover 422 togetherand by heat sealing connecter 423 to top surface 436 of cover 422. Forexample, each of connecter 423, cover 422 (or the combination of cover422 and connecter 423), and layer 420 may be pre-shaped and formed fromsemi-cured silicone. Once the connecter 423, cover 422, and layer 420are placed together appropriately, the entire member 419 may be heatedto heat seal and cure each of the three components to one another.Alternatively, for example, the cover 422 only may be made fromsemi-cured silicone while the connecter 423 and layer 420 may be madefrom fully cured silicone. Once placed together and heated, connecter423 and layer 420 will heat seal to cover 422. Semi-cured silicone maybe bought and pre-molded from a manufacturer such as NuSil Technology,for example.

Although the method of heat sealing the cover 422, connecter, and layer420 to each other is disclosed, it is within the scope of thisdisclosure to form member 419 by coupling layer 420, cover 422, andconnector 423 together by any other suitable means such as through theuse of adhesives, for example. Further, it is within the scope of thisdisclosure to provide a member 419 where cover 422 lies adjacent to, butis not coupled to, layer 420.

As mentioned above, cover 422 is coupled to layer 420 and connecter 423is coupled to cover 422 to form member 419. Cover 422 and layer 420cooperate to form distinct passageways 442 of member 419 defined bychannels 430, 431 of layer 420 and lower surface 434 of cover 422.Passageways 442 extend from the outer edges of member 419 and are incommunication with central area 428 of layer 420. Central area 428 oflayer 420 is in communication with port 440 of cover 422 which is incommunication with the vacuum and/or irrigation sources 16, 18, viaconnecter 423, and tube 441. Therefore, passageways 442 are incommunication with the vacuum and/or irrigation sources 16, 18.

Layer 420 includes through holes 446 which extend from channels 430, 431to wound facing surface 424, as shown in FIG. 30. Illustratively, holes446 are distinct and are provided to communicate with channels 430, 431of layer 420. Holes 446 therefore communicate with passageways 442 ofmember 419 and the vacuum and/or irrigation sources 16, 18 as well toallow the suction from the vacuum source 16 and/or the fluid from theirrigation source 18 to reach the wound bed surface 413 via the holes446. Illustratively, holes 46 are 0.020 inch (0.508 mm) in diameter andare spaced approximately 0.500 inch (12.700 mm) apart along channels430, 431 of layer 420. It is, however, within the scope of thedisclosure to include holes having other suitable sized diameters and/orother suitable spacing that allow for the removal of exudate withoutclogging.

Bandage 410 further includes a sealing layer or film 450 that is placedover cover 422 and around tube 441, as shown in FIG. 30. Film 450 actsas an outer cover of the bandage 410 and covers the entire wound 412 byextending over wound 412 and attaching to the patient's healthy skin452, also as shown in FIG. 30. Preferably, film 450 is an occlusive orsemi-occlusive material which allows water vapor to permeate through.Because of this characteristic, the film 450 is referred to as MoistureVapor Transmission Rate film or MVTR film. The products TEGADERM® brandsealing film made by 3M Corporation, and OPSITE FLEXIGRID®semi-permeable dressing made by Smith & Nephew can be used for film 450,for example. Film 450 is approximately 0.003 inch (0.076 mm) thick.However, it is within the scope of this disclosure to include anyocclusive or semi-occlusive film 450 having another thickness. Film 450is provided to create a sealed environment below the film 450 and aroundthe wound 200 in which a vacuum or negative pressure can be maintainedas provided by vacuum source 16. Film 450 therefore creates a vacuumspace 453 below film 450 and above wound surface 413.

As shown in FIG. 30, sealing film 450 is positioned adjacent to topsurface 436 of cover 422. It is within the scope of this disclosure,however, for bandage 410 to further include a packing material or fillersuch as gauze, for example, positioned between film 450 and member 419.

It is also within the scope of this disclosure to provide a bandage (notshown) having a self-sealing member which seals about the wound 412 tothe patient's healthy skin 27 to provide a vacuum space between themember and the wound surface 413. In other words, it is within the scopeof this disclosure to include a bandage having a sealing means withoutthe use of sealing film 450. For example, it is within the scope of thisdisclosure to include a wound contacting layer of the member having anadhesive positioned about the outer perimeter of the wound contactingsurface of the layer. The adhesive perimeter would be provided to sealto the patient's healthy skin 27 surrounding wound 200. The adhesivewould, therefore, permit the member to be self-sealing such that avacuum or negative pressure can be created and maintained above woundsurface 413 without the use of sealing film 450. It is also within thescope of this disclosure to provide any member having an adhesive forattachment to the patient's healthy skin surrounding the wound so thatthe member is self-sealing and able to maintain a negative pressureabove the wound without the use of a sealing film. For example, thewound contacting layer may be sized smaller than the cover and thebottom surface of the cover may include an outer adhesive perimeter forcoupling with the patient's surrounding healthy skin.

As shown in FIG. 30, member 419 of bandage 410 has a smooth wound facingsurface 424. Wound facing surface 424 may also be textured or roughenedand/or may include ribs, protrusions, channels, or spacers, or a singlerib, protrusion, channel or spacer design. By providing member 419 withone or more ribs, protrusions, channels, spacers, etc., a space iscreated between surface 424 of layer 420 and wound surface 413. Throughholes 446 communicate with this space to permit vacuum source 16 toestablish a generally uniformly distributed vacuum or negative pressureto the wound surface 413 to draw blood from the body to the woundsurface 413 and to draw exudate from the wound 412 through holes 446,into channels 430, 431 and passageways 442, and out port 440 of cover422.

Although bandage 410 is described above, it is within the scope of thisdisclosure for the ventilated vacuum bandage system to include anysuitable bandage or wound dressing member coupled to the vacuum source16 to communicate negative pressure from the vacuum source 16 to thewound 412. Bandage 410, therefore, is merely an illustrative bandage foruse with the wound care bandage systems disclosed herein.

The vacuum or negative pressure which draws blood from the body to thewound surface 413 and draws exudate from the wound 200 up through member419 promotes the healing of wound 200. As wound 200 heals, granulationsform along the wound surface 413. Granulations, therefore, are thereplacement within the wound bed of tissue lost. As the granulationsfill in the wound bed causing the wound 200 to heal, member 419 rides upon the wound surface 413 on top of the granulations which are formed.

As mentioned above, port 440 of cover 422 communicates with vacuumsource 16 and/or irrigation source 18 via connecter 423 and tube 441. Asshown in FIG. 29, switch valve 455 is provided which allows thecaretaker to switch between the use of the vacuum source 16 and theirrigation source 18. It will be appreciated that a mechanism other thanthe switch valve 455 may be used to selectively couple the vacuum source16 or the irrigation source 18 to the bandage 410. Simple tube clamps,for example, may be used selectively to open and close the tube setprovided with bandage 410. When valve 455 is switched to operate thevacuum source 16, the vacuum suction draws exudate up through holes 446and radially inwardly through passageways 442 toward port 440 andfinally through connecter 423 and tube 441. Although tube 441 has beenreferred to as vacuum tube 441, tube 441 may also be used as anirrigation tube carrying liquid to the wound 200 from irrigation source18, as described above.

As mentioned above, bandage 410 includes vent 460 similar to vents 19,119, 219 described above. Vent 460 also operates to increase air flowthrough the wound 200 and the passageways 442 of member 419 while vacuumsource 16 applies suction to wound 200. Without vent 460 a generallyclosed system is created between vacuum bandage 410 and vacuum source414. For example, in bandages without vent 460, once the requisiteamount of air in the tubing 441 and below sealing film 450 within vacuumspace 453 has been removed by the vacuum source 16 to create apredetermined negative pressure at wound surface 413, it is possible forthe system to become generally static inhibiting much, if any, fluidflow from wound surface 413 through passageways 442 and out port 440 andconnector 423. Vent 460, however, opens the system to aspirate thepassageways 442 and tube 41 of the system which promotes removal ofdebris that may be clogging the system.

Vent 60 acts as a first port of bandage 410 and port 440 of member 419acts as a second port of bandage 410. Bandage 410, therefore, includes afirst port in communication with the surrounding atmosphere above oraround bandage 410 and a second port in communication with the vacuumsource 16. When vacuum source 16 is running, a pressure differential isinitially created as vacuum source 16 draws mote air out from beneathsealing film 450 than is drawn in from the surrounding atmospherethrough vent 460. Therefore, a negative pressure is created above wound200. Once a desired negative pressure above wound 200 is reached, thatnegative pressure may be maintained so that the amount of air flow intothe bandage through vent 460 is generally equal to the amount of airflow out of the bandage 410 through connecter 423 and tube 441 by vacuumsource 16. The two ports of bandage 410 allow an air flow current to becreated beneath the film 450 to generally prevent the bandage 410 andvacuum source 16 system from becoming static.

As shown in FIGS. 29 and 30, vent 460 comprises a vent line or tube 462having a first end 464 and an opposite second end 466. Illustrative ventline 462 runs parallel to tube 441 and is coupled to tube 441 by one ormore couplers 468, as shown in FIGS. 3G and 31. First end 464 ispositioned to lie below sealing film 450 and above member 419. As shownin FIG. 30, first end 464 is adjacent top surface 436 of cover 422 andsecond end 466 of vent line 462 is positioned outside the vacuum space453 defined between wound surface 413 and sealing film 450. Thus, secondend 466 communicates with the surrounding atmosphere to draw air fromthe surrounding atmosphere into the system and through passageways 442of member 419. Although vent 460 is illustrated as a tube, it is withinthe scope of this disclosure for vent 460 to include any type of conduitor passage which provides communication between the atmospheresurrounding the bandage 410 and the passageways 442 of the bandage 410.

An air filter 470 similar to filter 34, described above, is coupled tosecond end 466 of vent line 462 as shown in FIGS. 29 and 30.Illustratively, air filter 470 is a 0.2 micron anti-microbial filter forpreventing bacteria and other microorganisms in the atmosphere fromentering the wound space below film 450. Filter 470 is also hydrophobic.Such an air filter, for example, is made by W.L. Gore & Associates, Inc.of Elkton, Md. A cap or a valve 472 is also coupled to second end 466 ofvent line 462. As shown in FIGS. 29 and 30, filter 470 is positionedbetween end 466 and valve 472. Valve 472 allows a user to manuallycontrol and adjust the amount of air flow into vent line 462. Forexample, valve 472 is movable between a fully closed position and afully opened position. In the fully closed position, no air flow ispermitted through valve 472 and the system operates as a closed system.In the fully open position, a maximum amount of air is drawn in throughthe valve 472 and vent line 462 so that the system operates as an opensystem to aspirate the passageways 442 of member 419 and create fluidflow throughout the system. The valve 472 is also adjustable to anydesired partially open position between the fully closed position andthe fully open position. Therefore, the amount of air flow through ventline 462 is adjustable by the caregiver.

While the valve 472 is open or partially open and air is being drawn inthrough vent line 462, vacuum source 16 will maintain a negativepressure under sealing film 450 while vacuum source 16 is operating. Inother words, the vacuum bandage 410 and vacuum source 16 act toinitially vent less air into the system than is vacuumed out of thesystem to create a negative pressure above the wound 200. Once created,the negative pressure above the wound 200 is maintained by vacuum source16 when vent line 462 is open. For example, even though vent line 462 isopen, vacuum source 16 is still able to create a negative pressure abovewound 200 as a result of the pneumatic resistance provided by the vent460. The vent line 462 and air filter 470 create pneumatic resistance tothe entry of air from the surrounding atmosphere into the space 453above the wound 200 when the valve 472 is open, thus enabling the neteffect to be a negative pressure above the wound 200 created by thevacuum source 16. In preferred embodiments, vent 460 is open orpartially open while the vacuum source 16 is operating. It is within thescope of the disclosure, however, to close the vent 460 while the vacuumsource is running.

Although vent line 462 is shown to run parallel to tube 441, it iswithin the scope of this disclosure to position vent line 462 anywhereso long as first end 464 is positioned below sealing film 450 and secondend 466 communicates with the surrounding atmosphere. Vent line 462 ofthe embodiment of FIGS. 29-31 comprises a separate tube formedindependently from tube 441 and coupled to tube 441 by couplers 468,such as medical tape wrapped around tube 441 and vent line 462. FIGS.32-33, as well as FIG. 4, described above, illustrate the cross sectionsof various alternative vent lines and vacuum/irrigation tubecombinations.

The embodiments shown in FIGS. 32 and 33 as well as FIG. 4 illustrateparallel vent lines and vacuum/irrigation tubes which do not require acoupler 68, for example, to maintain their parallel relationship. A ventline and vacuum tube combination 480 is shown in FIG. 32. Combination480 includes vent line passageway 482 and vacuum/irrigation passageway484 separated from vent line passageway 482 by a partition 486. As shownin FIG. 32, combination 480 has a circular cross-section defined by anouter wall 488. Combination 480 is extruded or manufactured as a singletube having two passages or lumens, whereas vent line 462 and tube 441of FIG. 31 are extruded or manufactured separately.

Another illustrative vent line and vacuum/irrigation tube combination490 is shown in FIG. 33. In combination 490, vent line 462 and tube 441are integrally coupled to each other. As illustrated, vent line 462includes an outer wall 492 and tube 441 includes an outer wall 494. Aportion of outer wall 492 is integrally coupled to a portion of outerwall 494. An external coupler 468, for example, is not required tomaintain the parallel relationship of vent line 462 and tube 441 ofcombination 490. Further, combination 490 is extruded or manufactured asa single tube having two passages or lumens.

Yet another illustrative vent line and vacuum/irrigation tubecombination is shown in FIG. 4 as multi-lumen tube 20 and was discussedabove with reference to system 10. Multi-lumen tube is a singlemulti-lumen tube having outer wall 25 and a central, inner lumen orvacuum passageway 22. Passageway 22 may be coupled at one end to eitherthe vacuum source 16 or the irrigation source 18 of system 410 and maybe coupled at the other end to connecter 423 of member 419 via thebarbed coupler 498, as shown in FIG. 3, and described in more detailbelow. As mentioned above with respect to system 10, multi-lumen tube 20further includes four outer lumens or air vent passageways 24.Passageways 24 are formed within outer wall 25 and around centralpassageway 22. Passageways 24 are in communication with the atmospheresurrounding bandage 410 at one end and are in communication with thevacuum space 453 below sealing film 450. Combination 500 is alsoextruded or manufactured as a single tube.

As shown in FIGS. 29 and 30, barbed tube coupler 498 is received withintube 441 and horizontal passageway 427 of connector 423. Coupler 498includes ridges 499 for preventing coupler 498 from separating fromeither tube 441 or connector 423. The vent line and vacuum tubecombinations 480, 490 of FIGS. 32 and 33 as well as multi-lumen tube 20of FIG. 4, are also coupled to connector 423 via coupler 498. Forexample, coupler 498 is received within tube passageway 484 of vent lineand vacuum tube combination 480 leaving vent line passageway 482 free todraw air into the bandage 410 from the surrounding atmosphere. Coupler498 is also received within tube 441 of combination 490 and vacuumpassageway 22 of multi-lumen tube 20. It is within the scope of thisdisclosure to further include combinations 480, 490 where vent linepassageway 482 and vent line 462 respectively, extend beyond tubepassageway 484 and tube 441 to space first end 464 of vent linepassageway 482 and vent line 462 away from tube passageway 484 and tube441.

Vent 460, shown in FIGS. 29 and 30, comprises vent line 462, filter 470,and valve 472 as mentioned above. However, it is within the scope ofthis disclosure to provide any vent in communication with both vacuumspace 453 and passageways 442 and with the surrounding atmosphere. Inother words, a vent is provided for communication between an areaoutside bandage 410 and an area within bandage 410 below film 450 or anyother sealing means to permit air to flow through the system to aspiratethe passageways 442 of the system and to allow the system to operate asan open system. The vent 460 is provided to create a fluid flow pathfrom outside the sealing means, through the sealing means to the member419 and finally through the holes 446 and passageways 442 of the member419 and out port 440 of member 419.

The air from vent 460 flows within the wound space 453 below film 450,or a similar sealing means, and above wound surface 413 of wound 200.For example, some air from the surrounding atmosphere reachespassageways 442 through openings at the peripheral edges of member 419and some reaches passageways 442 through holes 446 via various gapswhich may exist between wound surface 413 of wound 200 and wound facingsurface 424 of member 419. Further, ribs, protrusions, nubs, ortexturing on wound facing surface 424 act to promote air flow throughholes 446 by providing a space between wound surface 413 and woundfacing surface 424.

Although vent 460 is provided to create a fluid flow path from thesurrounding atmosphere through the passageways 442 of member 419 and outport 440 of member 419, it is within the scope of this disclosure forvent line 462 of vent 460 to also be used as a separate irrigation lineafter filter 420 and valve 472 are detached from line 462. This secondline may be connected to the irrigation source 18, for example, ratherthan be exposed to the surrounding atmosphere. It is therefore withinthe scope of this disclosure to connect second end 466 of vent line 462to irrigation source 18 to permit irrigation of bandage 410 and woundsurface 413 simultaneously with the operation of the vacuum source 16.

Although this invention has been described in detail with reference tocertain embodiments, variations and modifications exist within the scopeand spirit of the invention as described and defined in the followingclaims.

1. A vacuum bandage connectable to a vacuum source and provided for usewith a wound having a wound surface, the bandage comprising: a woundcontacting surface adapted to be in contact with and generally conformto the wound surface, a plurality of discrete passageways defined by anon-porous material, the passageways being configured for communicationwith the wound surface and with the vacuum source, and a vent incommunication with the passageways and configured for communication withthe atmosphere surrounding the bandage. 2-7. (Cancelled)
 8. A vacuumbandage connectable to a vacuum source and provided for use with a woundhaving a wound surface, the bandage comprising, a non-porous memberhaving a wound contacting surface adapted to be in contact with andgenerally conform to the wound surface, the member further includingdistinct passageways configured for communication with the wound surfaceand configured for communication with the vacuum source, an outer coveradjacent to the member to create a vacuum space between the cover andthe wound surface, the passageways of the member being positioned withinthe vacuum space, and a port in communication with the vacuum space andconfigured to communicate with an area outside the vacuum space tocreate a fluid flow path from the area outside the vacuum space to thevacuum space. 9-11. (Cancelled)
 12. A tubing set for use with a vacuumbandage coupled to a vacuum source, the vacuum bandage having a memberincluding a wound contacting surface adapted to be in contact with andconform to a wound surface, a port in communication with the vacuumsource, and a plurality of passageways in communication with the woundsurface and the port, the tubing set comprising: a first tube configuredto communicate with the port and the vacuum source, a second tubeconfigured to communicate with the passageways and the atmospheresurrounding the vacuum bandage to provide air flow from the surroundingatmosphere to the passageways of the vacuum bandage, an air filtercoupled to the second tube, and a valve coupled to the second tube, thevalve being operable between a closed position preventing air flow fromthe atmosphere to the vacuum bandage and an open position permitting airflow from the atmosphere through the filter to the vacuum bandage.
 13. Abandage for use with a wound comprising: a wound contacting memberadapted to be in contact with and generally conform to the surface ofthe wound, a vent in communication with the member and with theatmosphere surrounding the bandage to provide a passageway from theatmosphere to the member, and a filter coupled to the vent andconfigured to filter the air passing through the vent from theatmosphere to the member. 14-19. (Cancelled)
 20. A method for creatingcontinuous air flow above a wound surface while maintaining a continuousnegative atmosphere above the surface comprising the steps of: placing abandage over the wound surface and the bandage having a vacuum port anda vent, creating a sealed environment above the wound, connecting theport to a vacuum source, the vent being in communication with theatmosphere surrounding the bandage, and drawing air in from theatmosphere through the vent of the bandage, over the wound surface, andout the port of the bandage by operation of the vacuum source.
 21. Amethod for applying a negative pressure therapy to a wound surfacecomprising the steps of: applying a wound dressing member to the woundsurface, the member including a port for communication with a vacuumsource, a wound contacting surface having holes formed therein, andpassageways communicating between the holes and the port, applying acover to establish a vacuum space between the cover and the woundsurface, providing a passageway communicating between the vacuum spaceand the atmosphere to create an air flow path from the atmosphere to thevacuum space, through the holes and passageways, and out the port of themember, and operating the vacuum source to create a negative pressureabove the wound.
 22. (Cancelled)
 23. A system for ventilating a vacuumbandage covering a wound having a wound surface, and the bandage beingconnectable to a vacuum source and an irrigation source, the systemcomprising: a multi-lumen tube configured to couple to the vacuumbandage, the multi-lumen tube including a first lumen configured tocommunicate with the vacuum source, a second lumen in communication withthe surrounding atmosphere, and a third lumen in communication with theirrigation source, and a wound dressing member coupled to themulti-lumen tube, the wound dressing member being provided tocommunicate negative pressure from the vacuum source to the wound.24-57. (Cancelled)
 58. A wound bandage system for use with a wound, avacuum source, and an irrigation source, comprising: a wound bandage,and a vent apparatus through which ambient atmosphere vents to the woundbandage, through which irrigation fluid flows from the irrigationsource, and through which vacuum is communicated to the wound bandage.59. A vent-valve apparatus for use with a vacuum bandage coupled to awound to provide selective communication between the wound and either avacuum source or an irrigation source, comprising: a vent incommunication with the atmosphere and configured to communicate with thewound, and a stopcock coupled to the vent and in selective communicationwith the vacuum source and the irrigation source, the stopcock beingmovable between a vacuum position connecting the wound with the vacuumsource and an irrigation position connecting the wound with theirrigation source. 60-94. (Cancelled)
 95. A vent-valve apparatus coupledto a vacuum bandage for providing selective communication between thebandage and either a vacuum source or an irrigation source, comprising:a vent in communication with the atmosphere and the vacuum bandage, avalve coupled to the vent, a vacuum passageway in communication withvacuum source and the valve, an irrigation passageway in communicationwith the irrigation source and the valve, and a vacuum/irrigationpassageway in communication with the vacuum bandage and the valve, andin selective communication with the vacuum passageway and the irrigationpassageway. 96-107. (Cancelled)
 108. A method of wound care therapy isprovided for wound having a wound surface, comprising the steps of:applying a bandage over the wound surface to seal about the woundsurface, coupling a multi-lumen tube to the bandage to communicationwith the wound surface, the multi-lumen tube including an inner lumenand an outer lumen, coupling the inner lumen of the multi-lumen tube toa multi-lumen connector of an apparatus in selective communication witha vacuum source and an irrigation source, coupling an outer lumen of themulti-lumen tube to a vent in communication with the atmosphere,coupling a single lumen tube to an irrigation connector of the apparatusfor communication with the irrigation source, coupling a single lumentube to a vacuum connector of the apparatus for communication with thevacuum source, and moving the apparatus between a vacuum position wherethe vacuum connector is in communication with the inner lumen of themulti-lumen tube and an irrigation position where the vacuum connectoris in communication with the inner lumen of the multi-lumen tube.
 109. Amethod of wound care therapy is provided for wound having a woundsurface, comprising the steps of: coupling a bandage to a first fluidline and a second fluid line, coupling the first fluid line to a vent incommunication with the surrounding atmosphere, coupling the second fluidline to a valve in selective communication with a vacuum source and anirrigation source, and switching the valve between a vacuum positionwhere the second fluid line is in communication with the vacuum source,and an irrigation position where the second fluid line is incommunication with the irrigation source. 110-118. (Cancelled)
 119. Thewound bandage system of claim 1 wherein the vent apparatus comprises avent-valve apparatus.
 120. The apparatus of claim 58 and furthercomprising a filter coupled to the vent and configured to filter the airpassing through the vent from the atmosphere to the member.
 121. Theapparatus of claim 58 wherein the wound bandage is configured to lieadjacent the wound to create a sealed environment about the wound, thevent apparatus comprises a vent positioned between the bandage and thevacuum source, a vacuum passageway extends from the bandage, through thevent, to the vacuum source, and a vent passageway extends from thebandage to the vent in communication with the surrounding atmosphere.122. The apparatus of claim 58 wherein the wound bandage comprises awound contacting member adapted to be in contact with and generallyconform to a wound surface of the wound, a cover positioned over themember and configured to seal to the patient's healthy skin surroundingthe wound to create a space below the cover and above the wound, thevent appatus in communication with the space and configured forcommunication with the atmosphere surrounding the bandage, and a port incommunication with the space and configured for communication with thevacuum source.
 123. The apparatus of claim 58 wherein the vent apparatuscomprises a vent-valve apparatus, and further including a first singlelumen tube coupled to the irrigation source and the vent-valveapparatus, a second single lumen tube coupled to the vacuum source andthe vent-valve apparatus, and a multi-lumen tube coupled to thevent-valve apparatus and the bandage.
 124. The apparatus of claim 58including a vacuum passageway in communication with the wound and thevacuum source, an irrigation passageway in communication with the woundand the irrigation source, a ventilation passageway in communicationwith the wound and the surrounding atmosphere, and a valve coupled tothe vacuum passageway and the irrigation passageway to selectivelycommunicate the wound with either the vacuum source or the irrigationsource.
 125. The apparatus of claim 58 wherein the wound bandage isconfigured to lie adjacent the wound surface and seal about the woundsurface to provide a sealed environment below the wound surface, thevent apparatus comprising a multi-lumen tube coupled to the bandage andconfigured for communication with the wound surface, the tube includingan inner lumen configured to selectively communicate with the vacuumsource and the irrigation source, and an outer lumen in communicationwith the surrounding atmosphere, and a vent-valve assembly coupled tothe multi-lumen tube and movable between a vacuum position connectingthe inner lumen with the vacuum source and an irrigation positionconnecting the inner lumen with the irrigation source.
 126. Theapparatus of claim 58 wherein the wound bandage is adapted to bepositioned adjacent the wound to create a sealed environment around thewound, the vacuum source in communication with the bandage to create anegative pressure between the bandage and the wound, the vent apparatuscomprising a first passageway in communication with the bandage and withthe surrounding atmosphere, a second passageway in communication withthe bandage and with the vacuum source, and a third passageway incommunication with the bandage and with the irrigation source.
 127. Theapparatus of claim 58 wherein the vent apparatus comprises a multi-lumentube having a first lumen configured to be coupled to the vacuum source,a second lumen configured to be coupled to the irrigation source, and athird lumen in communication with the surrounding atmosphere, avent-valve apparatus coupled to the multi-lumen tube, the vent-valveapparatus having a vent coupled to the third lumen, a filter coupled tothe vent, and a valve coupled to the first and second lumens, thevent-valve apparatus provided to selectively communicate negativepressure and irrigation fluids to the wound while exposing the wound tothe surrounding atmosphere through the vent, a first single-lumen tubecoupled to the vent-valve apparatus and configured to be coupled to thevacuum source, and a second single-lumen tube coupled to the vent-valveapparatus and configured to be coupled to the irrigation source. 128.The apparatus of claim 59 wherein the stopcock comprises a bodyincluding a wound connector configured to communicate with the wound, avacuum connector configured to communicate with the vacuum source, anirrigation connector configured to communicate with the irrigationsource, and a handle rotatably coupled to the body and movable between avacuum position connecting the wound connector with the vacuum connectorand an irrigation position connecting the wound connector and theirrigation connector.
 129. The apparatus of claim 95 comprising amulti-lumen connector configured to communicate with the bandage, themulti-lumen connector including an inner conduit and an outer conduit, avacuum connector in selective communication with the inner conduit ofthe multi-lumen connector and configured to communicate with the vacuumsource, an irrigation connector in selective communication with theinner conduit of the multi-lumen connector and configured to communicatewith the irrigation source, and an opening in communication with theatmosphere and with the outer conduit of the multi-lumen connector. 130.The apparatus of claim 95 comprising an outer body including a centralaperture, a vacuum connector in communication with the vacuum source andthe aperture, and an irrigation connector in communication with theirrigation source and the aperture, a handle rotatably received withinthe aperture, the handle having a passageway formed therein, and amulti-lumen connector in communication with the wound having an innerconduit in communication with the wound and the handle, and an outerconduit in communication with the wound and the surrounding atmosphere.131. The apparatus of claim 95 including a body having an aperture incommunication with the vacuum passageway and the irrigation passageway,a rotatable handle received in part within the aperture and including apassageway configured to selectively communicate the vacuum passagewayand the irrigation passageway with the wound.